Hernia Mesh Patch Recall - FDA Warns of Death and Serious Healt...

Full story: PRWeb

Patients should review the latest recall information to see if they have been implanted with the recalled device and seek medical attention if symptoms such as unexplained or persistent abdominal pain, fever, ...
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2,861 - 2,880 of 8,067 Comments Last updated 1 hr ago
Joyce Merrick

Elkton, KY

#2968 Mar 17, 2010
Howie wrote:
<quoted text>
NO NO and NO!!
Parietex so far does not appear to have problems. What kind of problem does your son have?
However, Parietex is quite new and there could be long term problems, but not like UltraPro. I would see one of the surgeons I suggested.
Dr. Shirin Towfigh,
Dr. Peter S. Billing
etc. etc.
Dr. Kevin Petersen in LV
Dr. Clark Gerhart in PA
He has had pain in the abdomen since it was put it, he now has a bulging area in about the same place as the other hernias were and it hurts him quite a bit. He has had burning and pain in the areas where the mesh was attatched.
Howie

Washington, DC

#2969 Mar 17, 2010
Joyce Merrick wrote:
<quoted text>
He has had pain in the abdomen since it was put it, he now has a bulging area in about the same place as the other hernias were and it hurts him quite a bit. He has had burning and pain in the areas where the mesh was attatched.
Hi Joyce,
Did your son have a groin hernia (inguinal) hernia? If he had something else, please call Dr. Guy Voeller
Howie
Currently Traveling in Sacramento, CA
cindy15717

Pittsburgh, PA

#2970 Mar 17, 2010
Michael wrote:
<quoted text> Dave be very careful of some people on this forum, either docs drumming up business for themselves or what ever just do what you feel is the right thing and if you decide on Surgery tell your surgeon not to use any thing by Bard or Davol.
Dave maybe you could get a belt to wear if they arent bothering you much please make sure , Ihad no choice but get operation for hernias but now I wished i would of checked on mesh he was using & his back ground . My doc operates in pa was banned in New Jersy i wasnt carefull enough
Back to the hernia belts they are bout 40 dollars can even get them on Ebay . & if People didnt know you can buy Bard < Davol Mesh on Ebay too

Everyone of us thta had the operations we suffer daily & no where to turn
Michael

Fort Myers, FL

#2971 Mar 17, 2010
Sad but true I had 8 operations the last being in Dec 2007, coded on the operating room table and almost coded in my room at the hospital, now guess what I have another Hernia along the incision OMG does it ever end.
Dave

Rapid City, SD

#2972 Mar 17, 2010
Restaurant Man wrote:
I had a McVay repair by Dr. Kevin Petersen and had little pain after. Hey Dave, so what if overhead costs are less? What difference is it to you if works?
Let people know how well your repair holds up in about 5 years
Seth

Houston, TX

#2973 Mar 18, 2010
Can anyone find statistics on how Parietex mesh is doing vs. UltraPro?
I believe Parietex mesh is supposed to have smaller shrinkage characteristics.

Maybe there has been a recent paper published, etc.

Howie has said that Parietex being Polyester based is better than Polypropylene and the reason they had trouble with Polyester type meshes that it was hard to sterilize. Actually, mesh has a long history of trouble.
A fact that is true: They don't put mesh in babies born with hernias. They use stitching and it usually works for about 50 years. But any fabric will deteriorate after 50 years.
Michael

Fort Myers, FL

#2974 Mar 18, 2010
I think alot of you are missing the point on this issue. The point is that the wat the mesh is manufactured with 2 layers so that they dont stick together or any thing else that is not supoosed to stick together is that it seperates. That is the trouble with the EPFT mesh, it seperates and splits into 2 different objects causing it to cut open bowels and or exterior abdomen cavities like it did to me and many others. Its in the manufacturing of the mesh. There is an interesting few articles on clarislaw.com . They have published all the info that you need to read about. Nope Im not saying I am with them. Its your choice to pick and choose, but they seem to have the most info and updated.
Howie

Washington, DC

#2975 Mar 18, 2010
Some states have a 3 year limitation on lawsuits against doctors. Is this a hard and fast rule?
Michael

Fort Myers, FL

#2976 Mar 18, 2010
Howie wrote:
Some states have a 3 year limitation on lawsuits against doctors. Is this a hard and fast rule?
Yes Howie its three years or 3 years from the date you first are told that thier was damages. However, if you are referring to any Kugel litigation then you can try and join in on the case as a tag-along to the MDL-1842 (That is the Kugel lawsuit in RI). Unfortunately you have to sign a paper stating that you will not sue either the hospital or the surgeon that implanted the Mesh product. Np way around that one, because they are claiming that the Surgeons were duped just as well as we were.
Michelle

Bremerton, WA

#2977 Mar 19, 2010
To ALL INTERESTED IN DISSOLVABLE STAPLES:
To Michelle, the last I heard you had surgery at OHSU in Portland with Dr. John Hunter and a member of a visiting Austrailian Surgical Team with Dr.
O'Donnel Clark, Jr. I am happy for the way things went and your mesh removal/replacement. Can you tell me when they did the replacement with Parietex if they used dissolvable staples? I think many surgeons just do the Parietex install and do not use the dissolvable staples (or tacks).

I am doing very well with my mesh replacement. I told the surgeon's I did not want the absorbable tacks based on what I had read that they really do no in general cause problems, so my mesh removal replacement was with the Parietex mesh and Titanium tacks. So far doing very well. I had read many reports that the Hernia MD and Dr. Ramshaw favored the absorbable tacks but if there is a problem with mesh rejection down the road, then absorbable tacks are useless. Parietex is fairly new to the market and it is true that nobody is publishing reliable statistics on different meshes because of financial interest in these companies. Dr. Hunter in Oregon often trains other surgeons although he is not a hernia expert. He is a top lap expert!! So we need to read between the lines of Dr. Ramshaw, etc for what may be the real answer. I choose not to have the dissolvable tacks and made it clear but wanted the Parietex I think the inguinal area is a problem from birth of a weakened area. Why some people get hernia and some don't it would be nice to know.
Michelle

Bremerton, WA

#2978 Mar 19, 2010
If Karen is reading this, I just want you to know I did not see Dr. Perin at NW Hospital in Seattle for a stitch repair. The last I heard, you were doing great, please email me if you get a chance. I know you wanted it done the old way as she does both the old way and mesh repair. I did not try to interview any surgeons up here while visiting. There are many females getting groin hernias and you just don't hear about it all that much or they keep it to themselves.
Seth

Houston, TX

#2979 Mar 19, 2010
The American Hernia Society Meeting is going on now. The sponsors are mostly mesh companies.
Seth

Houston, TX

#2980 Mar 19, 2010
Dr. Reginald Bell in Colorado is currently using the Kugel patch for many of his surgeries. So it is a fallacy that the Kugel repair is gone.
Michael

Fort Myers, FL

#2981 Mar 20, 2010
Seth wrote:
Dr. Reginald Bell in Colorado is currently using the Kugel patch for many of his surgeries. So it is a fallacy that the Kugel repair is gone.
Yes and No Seth, they have once again been able to modify it, using a differen kind of ring, rather than a non flexiblwe ring this one is a flexible one. No, I am not a representative just highly motivated on Kugel, because I was injured by thier crap.
Seth

Houston, TX

#2982 Mar 20, 2010
Michael wrote:
<quoted text>Yes and No Seth, they have once again been able to modify it, using a differen kind of ring, rather than a non flexiblwe ring this one is a flexible one. No, I am not a representative just highly motivated on Kugel, because I was injured by thier crap.
Michael, the question I have for you is even if the memory ring is modified to keep in from retracting or collapsing, can it still "migrate"? And Michael, it may have been ALS (in Seattle) had told me Dr. Kugel used to have an office in the Seattle area and had a popular hernia webssite at one time. He closed the website and eventually was down to one office in Olympia, Washington.

Now you say the current patch has a flexible ring? Is this ring made out of "Nitonol" like the Rebound HRD that "Dave" on this forum used to talk about? Just studying this Kugel patch idea,
I get the impression mesh really has it's problems because of a small percent of people who reject these "foreign" substances. The doctor's are not warning the patients and never warned me and others that mesh has it's problems.

Do you know if Dr. Kugel was ever sued or just the manufacturer of his mesh? I think it is very hard to sue an individual surgeon because it takes a lot of legal expertise to fight them. Instead they go after the manufacturer. If they can sue the manufacturer of the Kugel patch then why not the manufacturer of other mesh products like those companies who used to make Marlex, UltraPro, etc.
Michael

Fort Myers, FL

#2983 Mar 20, 2010
Seth: Unfortunately I do not have all the answers, I need to start out by saying that I am one of those ppl that were injured by the Composix mesh manufactured by Davol. So with that out of the way I can go on.Davol has said that they modified it to keep the ring from expanding and breaking. At first they claimed that the Surgeons were putting the mesh in wrong. But the FDA said it was the manufacturing plant in San Juan that was making it and packaging it wrong. Yes Doctor Kugel the inventor of the mesh did have an office and a popular website on Hernias. Welll I would be embarrasssed as well if I manufactured a piece of garbage that injured many people too. Yes the mesh can still migrate according to things I have read and researched. As for the type yes it is. It is not rejection of the mesh but it is the way it migrates and falls apart which causes it to break into the walls of the abdomen and the teflon cuts open the colon. According to the lawsuit that has been filed in the RID court is that the Surgeons were unaware of this problem so they were duped just as much as the patients. So the surgeons either are not to blame or not at fault. As for Dr Kugel he was never sued but the manufacture has been sued. You should look it up at www.rid.us court home page then look for MDL-1842. Currently it is being pursued in the courts under Rhode Island district court. Each case is going on its own merit even though it has been consolidated in the above said court. The agreement was that you would not sue the surgeon as for the reasons stated above. They can but first either you or the Surgeons must file an adverse event report with the FDA. You can either call them or email them on how to do this. I just happened to be lucky to be able to sue the manufacturer because the surgeon who took the mesh out told me about it and also I did alot of research on the issue. So my friwend you should try and do the same. You need your Surgical records that has the implntation label. All things that are implanted in the body get labeled with the manufacturer sticker on the operation report.Luckily I worked in the Surgical dept in the medical field or else I would have had a hard time finding this out as well. So good luck if you have any further questions you can email me at brennanone@msn.comI did research on Marlex and Ultrapro also. Marlex had some trouble, but it was originally intended for slings for women who were dropping thier bladder and vaginal organ. They to have had a few complications.

Mike
Michael

Fort Myers, FL

#2984 Mar 20, 2010
also Seth My surgeon had stated to me the one that took the mesh out of me said that they havent used that type of mesh in 2 years that was back in 2006. He was highly aggraavated when the original surgeon inplanted me with the Composix. So I really did have the hint.The rest was up to me.
ALS

Houston, TX

#2985 Mar 21, 2010
In regards to Dr. Kugel, I visited him in 2005 in his Olympia office. At that time he was only down to one office but some of the phone books showed 2 offices and a website which did not work. I had pain from both a marlex mesh on one side and a prolene PHS mesh on the other side. Both meshes had retracted as it was discovered later. Dr.Kugel in my opinion look a little out of it or should I say he looked aloof. I think at that time floods of stories from his Kugel patch were starting to come in. He did not want to take existing meshes out and replace them with the Kugel patch. His office was subsequently closed about a year or so later.

Michael or anyone, I have looked at all of my operative reports and they do not give specific numbers or manufacturing codes or lot numbers. Are these numbers on other records? In my opinion, I don't think it is just the Kugel patch manufacturers but I think all manufacturers who have touted these meshes who don't say there are a percentage of people that could have severe rejection problems with them. So far in my case, I have the UltraPro as a replacement and have done much better. But Dr. Ramshaw was evaluating "explanting" meshes to see what they do. Some meshes become brittle in a short period of time. I think this "brittleness" leads to stiffness and therefore the mesh cannot stick to the muscle walls so it just folds up under pressure. The brittleness is caused by oxidation and chemical deterioration. The surgeon will not admit it, but that is basically what has happened. Also, like others have said, mesh is like an organ transplant. Your body does not like foreign substances.

A friend of mines father had a hernia repair using stitches. He spent a couple of days in the hospital because back then it was "required' to do so.
When he got home he recovered well and the hernia come back. He went back to the surgeon and he redid the repair. He never had any problems since. Like I say, in the old "stitch" methods even if there were problems like it coming back, they addressed it and that was the end of it. Every person I knew who had the "stitching" done the old way came out fine. This is contrary to the surgeons posting on this board and that board.
My email address is "swimmerinshoreline@Yahoo .com"
ALS
Emmerson

Las Vegas, NV

#2986 Mar 21, 2010
Can anyone fill me in on Dr. Bruce Ramshaw a former hernia surgeon in Missouri? I have read some posts about him and he is multi-faceted for several reasons: researcher, experience in open repairs, and lap surgeries which different meshes and techniques.

Another surgeon is Dr. Robert Burns in California at Newport Beach California?I understand he does the Desarda Repair. I am not sure I want to travel to a congested area like LA and Newport Beach.

My other choice is Dr. Peter S. Billing in Seattle, Washington. He is from the Mayo clinic and in totally private practice. Those surgeons from the Mayo clinic in my opinion seem like they would be about the best, so I am leaning this way to go with Dr. Billing. And a couple of people commented on him.

I am very much afraid of government mandated health insurance. I know this will be phased in over several years but what may happen is these great surgeon like some of you have mentioned will be forced to quit or follow government mandated standards which preclude innovation and what is best for the patient. Whereas someone who has gone to Dr. Ramshaw and had a mesh removed and had his pain and problems resolved, this type of procedure may require a long waiting time or could even be prohibited. Or if you are a certain age, they may say just live with it to save money as the government goes broke. It is very scary. I cannot name my original surgeon but my inguinal repair left me in pain. This hospital was located in Cleveland. They wanted me to take OTC pain pills. Now my blood pressure is high.

I would appreciate any suggestions for a good surgeon. I am thinking about the Seattle area because it is a little easier to drive and get directions if all other things are equal.
hurt for every my bard

Flushing, NY

#2987 Mar 22, 2010
Emmerson wrote:
Can anyone fill me in on Dr. Bruce Ramshaw a former hernia surgeon in Missouri? I have read some posts about him and he is multi-faceted for several reasons: researcher, experience in open repairs, and lap surgeries which different meshes and techniques.
Another surgeon is Dr. Robert Burns in California at Newport Beach California?I understand he does the Desarda Repair. I am not sure I want to travel to a congested area like LA and Newport Beach.
My other choice is Dr. Peter S. Billing in Seattle, Washington. He is from the Mayo clinic and in totally private practice. Those surgeons from the Mayo clinic in my opinion seem like they would be about the best, so I am leaning this way to go with Dr. Billing. And a couple of people commented on him.
I am very much afraid of government mandated health insurance. I know this will be phased in over several years but what may happen is these great surgeon like some of you have mentioned will be forced to quit or follow government mandated standards which preclude innovation and what is best for the patient. Whereas someone who has gone to Dr. Ramshaw and had a mesh removed and had his pain and problems resolved, this type of procedure may require a long waiting time or could even be prohibited. Or if you are a certain age, they may say just live with it to save money as the government goes broke. It is very scary. I cannot name my original surgeon but my inguinal repair left me in pain. This hospital was located in Cleveland. They wanted me to take OTC pain pills. Now my blood pressure is high.
I would appreciate any suggestions for a good surgeon. I am thinking about the Seattle area because it is a little easier to drive and get directions if all other things are equal.
I have heard that a surgeon names Dr. Robert Miller a plastice surgeon in Atlanta at Peidmont Hospital is great at removing these mesh materials...he is a good reconstructive surgeon as well.

make sure you keep all your documention in regard to the mesh complications.

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